Hybrid L24 New Enrollment Post Approval Study

Completed · Not applicable

Conditions studied: High Frequency Sensorineural Hearing Loss

In brief

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Key facts

Study ID

NCT02379819

Run by

Cochlear

People needed

52

Starts

2015-02-01

Expected to finish

2022-04-14

Last updated by the study team

2023-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ear to Be Implanted:
• Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted
• CNC word recognition of 10-60% in the ear to be implanted
• Contralateral Ear:
• Moderately severe to profound mid to high frequency hearing loss in the contralateral ear
• CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct

You may not qualify if…

• not proficient in English
• unwilling and/or unable to comply with the test protocol
• deafness due to lesions of the acoustic nerve or central auditory pathway.
• active middle-ear disease, with or without tympanic membrane perforation.
• absence of cochlear development.
• duration of severe to profound hearing loss of 30 years or greater

Where it is running

• Arizona Ear Center — Phoenix, Arizona, United States
• Kaiser Permanente South Sacramento — Sacramento, California, United States
• University of Colorado Hospitals — Aurora, Colorado, United States
• Denver Ear Associates — Englewood, Colorado, United States
• Rocky Mountain Ear Center — Englewood, Colorado, United States
• University of Miami — Miami, Florida, United States
• NorthShore University Health System — Northbrook, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Michigan Ear Institute — Farmington Hills, Michigan, United States
• Midwest Ear Institute — Kansas City, Missouri, United States
• The University of Cincinnati — Cincinnati, Ohio, United States
• Ohio Ear Institute — Westerville, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Pittsburgh Ear Associates — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Ear Institute of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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